FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
- Recall number
- Z-0977-2015
- Recalling firm
- SpineFrontier, Inc.
- Product
- lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
- Status
- Terminated
- Initiated
- 2014-12-19
- Posted
- 2015-01-14
- Terminated
- 2016-01-11
- Reason
- A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
- Root cause
- Device Design
- Action
- Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.
- Quantity
- 4 devices
- Distribution
- Nationwide Distribution including TX, OH, VA, and Washington, DC.
- Lot, serial or model codes
- Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3005977257
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28